Pimplin’ Ain’t Easy

By Benjie Cooper

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Acne affects an estimated 633 million people worldwide and ranks as the 8th most common disease among humans. Caused by a variety of factors including genetics, hormones, stress, and environmental elements, it’s a condition that is most prevalent during adolescence, but it does affect children and adults as well. While acne is not a life-threatening condition, physical scars, depression, and self-esteem issues are common effects of the skin disease.

People around the world routinely apply medicated creams, take oral antibiotics and hormone drugs, and moderate their diets in hopes of quelling the often numerous red bumps that continue to manifest across their skin. There is some definite success that some who experience positive outcomes can claim with the use of modern acne treatments, but results can vary, and current remedies can come with side effects like dry and peeling skin, inflammation of the whites of the eyes, dizziness, and joint and back pain. The vitamin A-derived drug Accutane has even been linked to congenital disabilities.

On July 3, Australian clinical stage medical dermatology company, Botanix Pharmaceuticals announced the successful completion of its open-label Phase 1 study of its lead acne program; BTX 1503. The objective of the trial was to “determine the safety, tolerability, and pharmacokinetics (PK) of a single dose and 14 days of treatment with BTX 1503 in healthy volunteers.” In short, they wanted to find out what quantity of the product people could safely take.

Botanix initially announced the trial’s commencement on May 8. In a press release, Executive Director Matt Callahan stated that “This first study is designed to provide safety, dosing and pharmacokinetic data for BTX 1503…This study will also form the basis for our planned dermatitis program, which we expect to accelerate into the clinic later this year…”

BTX 1503 is a synthetic cannabidiol (CBD) product that Botanix is developing to reduce oil (sebum) production in the skin and reduce inflammation and bacterial infection. The solution is administered via Botanix’s recently-licensed skin delivery technology called Permetrex which is designed to deliver the compound into the proper layer of skin where it stays.

Botanix Executive Director, Matt Callahan says that “Our use of synthetic cannabidiol substantially increases the likelihood that Botanic products can satisfy the stringent FDA requirements for purity and consistency and avoids the risks associated with natural, extract-based products…just like the earliest forms of Aspirin were extracted from the bark of the willow tree, today we wouldn’t think of using a natural extract when we can chemically synthesize pure aspirin at industrial scale for pain relief. The use of cannabidiol for pharmaceutical treatments needs to go the same way, and Botanix is leading that development with our skin disease products.”

At each session during the trial, the study’s twenty volunteers were monitored for signs of dryness, burning/stinging, irritant/allergic contact dermatitis, scaling, dryness, and erythema (redness). After all of the volunteers completed the single, multiple, and rising dose stages of the trial, Botanix announced that there were a few incidents of mild side effects, of which, the most common was a slight dryness of the skin which the company says is consistent with how BTW 1503 works. The company is currently preparing to submit an ethics application to conduct a new pilot CBD study which will include the Phase 1 data.

But even as Botanix is pursuing a new acne remedy using a synthesized cannabinoid, the idea of using natural CBD to combat the skin condition is not a new one. In 2009, Professor and Chair of the Department of Immunology at the University of Debrecen in Hungary, Dr. Tamás Bíró conducted research using cannabidiol due to its legality and availability in the country. Because CBD is non-psychoactive, it is not banned under Hungarian law.

Sebaceous glands in the skin secrete an oily lipid called sebum which serves to help waterproof the skin, but when the glands produce too much, acne is the result.

Sebaceous glands (sebocytes), surface keratinocytes (outer skin cell type), and hair follicles all have endocannabinoid receptors, but Bíró discovered that CBD works through ion channels on sebocytes. Bíró applied CBD in a methanol-ethanol solution to cells that had been treated with the endocannabinoid, anandamide (the human body’s version of THC) and found that it inhibited lipid production, even though he and his associates thought that it would do the opposite and increase it.

Vitamin A derivatives like Accutane inhibit the production of sebum by killing the sebaceous glands which in turn creates dry skin and causes itching. Bíró and his colleagues demonstrated that with the application of cannabidiol, it suppressed lipid production without destroying the integrity of the cells or their ability to operate normally.

Cannabidiol is showing promise as a treatment for acne in both synthetic and natural forms. Given that many people routinely use CBD as an aid for anxiety and depression, it appears the cannabinoid can not only help treat physical scars caused by acne but the mental ones as well.